JP4540987B2 - Stent delivery device - Google Patents

Abstract

A filter assembly (931; 1031) adapted to capture embolic particles or material that during a procedure, the filter assembly including a filter basket (934), and a filter (933; 1133). The filter assembly can be in a restrained condition or in a deployed condition and wherein before deployment, filter (933; 1133) can be disposed inside filter basket (934), surround filter basket (934), or a combination thereof.

Description

  The present invention relates generally to the field of interventional cardiology. More particularly, it relates to interventional cardiology-based procedures that require placement of a stent within the body lumen of a patient or animal. The present invention further relates to a system for preventing embolization of stent placement within a body lumen.

  Human blood vessels are often occluded by plaques, thrombi, other deposits, or substances that reduce the blood transport ability of the blood vessels. Occlusion at critical locations in the circulatory system can cause serious and permanent damage and even death. To prevent this, some form of medical intervention is usually performed when a major occlusion is detected.

  Several approaches are currently used to widen the blood vessels of patients that are constricted or occluded by plaque or other substance deposits that form on the vessel wall of the vessel. For example, angioplasty is a widely known technique and introduces an inflatable balloon into the occluded region. The balloon is inflated to expand the occluded portion, thereby increasing the lumen inner diameter.

  Another technique is atherectomy. During atherectomy, a catheter is inserted into the stenosed artery to remove material that occludes or narrows the artery, ie, fat. The catheter includes a rotating blade or cutter placed on top of it. An opening is also positioned at the tip, and a balloon is disposed at a position opposite to the opening at the tip of the catheter. When this tip is placed close to the fat, the balloon is inflated to bring the opening into contact with the fat. As the blade rotates, some of the fat is scraped away and held in the lumen of the catheter. This process is repeated until a sufficient amount of fat is removed and substantially normal blood flow is resumed.

  Another approach treats stenosis in an artery or other blood vessel by introducing a stent into the stenotic region to widen the vessel lumen. Stents generally include a substantially cylindrical tube or mesh sleeve made of a material such as stainless steel or Nitinol. With this material design, the diameter of the stent can be expanded radially and sufficient rigidity can be obtained so that its shape is maintained after the stent is expanded to the desired size.

  A number of medical devices are commonly used to place stents. Normally, once entry into the arterial system is established via the femoral artery, a guide catheter is inserted into the artery and its tip is guided to a position very close to the stenotic region to be treated. This guide catheter is suitable for the purpose of promptly delivering another device to the position without the need to carefully guide from the entry point to the point of intervention through the arterial tortuous structure.

  Generally, a small diameter guide wire is then inserted through the guide catheter and guided to the distal point of the stenotic region. Once the guidewire has entered the lesion, if the cross-sectional area of the narrowed portion of the lesion is sufficiently large, a stent attached to the delivery device is introduced along the guidewire. Once correctly positioned within the stenosis region, the stent is deployed and the vessel is widened in such a way that a strut is sandwiched within the vessel.

  In such cases, various types of stents are used, but typical stents require the stent to be deployed or expanded from its compressed state by a balloon attached above. The balloon is inflated from the proximal end of the delivery device to high pressure, which results in an increase in stenosis and the implantation of the stent in the lumen of the blood vessel at that location.

  Once the guide wire is in place, it is used as a guide for all other devices used in this approach. These devices have a lumen through which the proximal end of a guide wire external to the patient's body is inserted. The device is then slid along the guide wire into the body, and the guide wire guides the device to the required location in the vasculature. The process of sliding another device along the guide wire is commonly known as an exchange.

  Two basic types of devices facilitate the exchange between the stent system and the inflatable balloon. The first type of device encapsulates a guide wire within the lumen over the entire length of the device. The second type of device encapsulates a guide wire only in the small distal segment portion of the device, and the remaining guide wire exits from the device lumen through a side hole so that the device and guide wire are It is designed to be parallel. In either case, if the precise positioning of the device relies on maintaining the guidewire position, the control of the guidewire during the exchange will be superior and will be enclosed in the lumen of the device being exchanged. This is difficult if at least part of the guide wire is not allowed to enter due to the fact that it is.

  By providing a stent delivery device that reduces the complexity of the insertion procedure, stent delivery technology is developed. In addition, stent delivery technology is developed by reducing the number of devices used in performing the stent implantation method.

  In addition, when these interventional approaches are implemented, embolic particles can be destroyed and flow downstream, causing adverse events. Therefore, devices designed to capture and filter such particles in order to prevent them from flowing downstream and to occlude blood vessels during the intervention and to aspirate these particles before flowing further downstream. It is appearing.

  The current technology of embolic protection devices requires delivery of the device into a sheath distal to the intervention site. To that end, it is necessary to cross the lesion and a device having a large diameter and relatively hard, and doing so may cause an embolization phenomenon before the embolism prevention device is put in place. The sheath must then be removed and a filter deployed in the vessel. After deploying the device, the area in question can be treated by exchanging balloons, stents, or other selected treatments along the device. Once this procedure is complete, the embolic protection device is captured by another catheter exchanged along the embolic protection device that captures any possible embolic material. This relatively complex approach also increases the complexity of stenting and other approaches.

  The devices and methods described herein overcome the shortcomings of current devices and allow faster, safer and easier prevention and stenting.

  Embodiments of the present invention include a system that incorporates the functionality of a guidewire, stent delivery device, expandable balloon, and embolic protection device, or subsets thereof, into a single device that can be inserted into a body lumen. Methods and apparatus can be provided. Thus, embodiments of the present invention reduce the number of devices required to perform a procedure, reduce the time required to perform the procedure, reduce the difficulty and complexity of the procedure, and thereby It is possible to perform a safer treatment and increase the effectiveness for the patient.

  In one embodiment, the delivery device includes a guide member having a distal end and a proximal end. The guide member functions as a guide catheter, a guide wire, and a stent delivery device. At the distal end of the guide member is disposed an expansion assembly and a stent pre-mounted on the expansion assembly. In order to selectively maintain the expandable assembly and stent within the lumen of the delivery device, the distal end of the guide member is configured to apply a restrictive force to the expandable assembly. Coupled to the distal end of the guide member is a restricting member or mechanism that can be manipulated to release the restricting force applied to the expandable assembly and stent, thereby allowing the expandable assembly and stent to Can be deployed from within the lumen. The restriction mechanism cooperates with the actuation assembly so that the expandable assembly and the stent are deployed.

  In one embodiment, the actuating assembly includes an actuating member that cooperates with the proximal end of the guide member and extends from a restriction mechanism or member at the distal end of the delivery device to an actuating element disposed at the proximal end of the guide member. Including. Therefore, movement of the actuating element is transferred to the actuating member to release the restricting mechanism or member, whether alone or in combination with the distal end of the guide member. To release the restraining force applied to the expandable assembly and / or stent.

  In operation, the delivery device is in place within the lumen of the patient's body, and the expandable assembly and stent are in a regulated position. Operation of the actuation assembly releases the expandable assembly and stent from the interior of the guide member. The guide member can be retracted proximally to completely free the expandable assembly and stent from the guide member. Alternatively, the expandable tube and / or positioning member connected to the expandable assembly can be advanced distally to deploy the expandable assembly and stent. The stent is then placed within the vasculature, for example, by inflating an expandable balloon that is coupled to the expandable assembly via an expandable tube. After the stent is implanted, the expandable assembly can be deflated to remove the delivery device from the patient.

  According to another aspect of the invention, the delivery device includes an embolic protection device adapted to collect embolic particles released during the procedure. When the stent is implanted, the embolic protection device can filter the blood that has passed through the lesion to prevent the embolic particles or material from flowing downstream. In one configuration, an anti-embolization device is attached to the distal end of a guidewire coupled to the delivery device. The embolic protection device may be a filter assembly that includes a filter and a filter basket. The filter basket includes a plurality of struts that regulate the filter while the delivery device is inserted into the body lumen and also release the restraining force applied to the plurality of struts. Sometimes it supports and unfolds the filter, thereby maintaining the filter assembly in the closed position during insertion of the transport device. The structure used to apply the regulatory force to the plurality of struts may be similar to the structure that applies the regulatory force to the expandable assembly and / or stent.

  According to another aspect of an embodiment of the present invention, the transport device can cooperate with the capture mechanism or device to retrieve the filter assembly without removing the transport device from the body.

  Thus, with the delivery device of the present invention, it is possible to achieve a protected insertion by inserting a single device without replacement, while contacting the guidewire distal to the treatment area throughout the procedure. It is possible to make it.

  These and other objects and features of the invention will become more fully apparent from the following description and appended claims, and may be learned by the practice of the invention as set forth hereinafter.

  To further clarify the above and other advantages and features of the present invention, the present invention will be described in more detail by reference to specific embodiments of the invention illustrated in the accompanying drawings. It will be understood that these drawings depict only typical embodiments of the invention and are therefore not intended to limit the scope of the invention. The invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

  The present invention provides the functionality of a guide catheter, guidewire, stent delivery device, expandable balloon, and / or embolic protection device, or a subset of such devices, in a single device that can be inserted into a body lumen. Incorporated systems, methods, and apparatus are provided. Thus, the present invention can reduce the number of devices required to deliver and position the stent, reduce the time required to perform the procedure, and the difficulty and complexity associated with performing the procedure. To reduce. Furthermore, embodiments of the present invention help to reduce the likelihood that a patient will suffer complications during and after treatment.

  Referring to FIG. 1, an exemplary embodiment of a transport device of the present invention, indicated by reference numeral 10, is shown. As shown, the delivery device 10 includes a guide member 12 having a distal end 14 and a proximal end 16. The term “guide member” can refer to any structure capable of functioning as a guide wire that can be navigated through tortuous structures within a patient's body. It will be appreciated that the guide member 12 may be hollow or partially hollow depending on design issues.

  A lumen 18 extends between the distal end 14 and the proximal end 16 of the guide member 12, and an expandable assembly 40 and a stent 42 are disposed therein (see FIG. 2). The distal end 14 of the guide member 12 includes a tip 15 configured for percutaneous insertion into a body lumen, while the proximal end 16 is adapted to deploy the assembly 40 and / or stent 42. Includes or is adapted to cooperate with the actuating assembly 20.

  By way of example, the outer diameter of the guide member 12 may be between about 0.010 inches (0.25 mm) and about 0.650 inches (1.65 cm), and the inner diameter or lumen 18 diameter is about 0.004 inches ( 0.10 mm) to about 0.55 inch (1.40 cm). Furthermore, the guide member 12 can be made from a variety of different materials. For example, the guide member 12 may be made of Nitinol, steel, metal, metal alloy, composite, plastic, polymer, synthetic material, such as, but not limited to, PEEK, Rydel, or combinations thereof. Further, the guide member 12 may have a configuration of a blade reinforced polymer tube or a hard polymer tube. Furthermore, the guide member 12 can be covered with one or more coatings. For example, the guide member 12 can include, but is not limited to, one or more coatings that improve lubricity, reduce platelet aggregation, or have antithrombogenic properties. In addition to the above, the guide member 12 may position and / or position the guide member 12 in one or more hydrophilic coatings, heparinized coatings, polytetrafluoroethylene (PTFE) coatings, silicone coatings, or combinations thereof. Other coatings can be included to help prevent damage to the lumen.

  Optionally, the guide member 12 is one or more cutting portions, slits, grooves, or other structures, exemplarily indicated by reference numeral 17, which provide a structure that provides flexibility to all or part of the guide member 12. May include. Although the use of cuts, slits, or grooves to provide flexibility has been described, those skilled in the art will recognize that guide member 12 or other portions of device 10 may be part of guide member 12 and / or device 10. It will be appreciated that it may have a lattice structure that provides flexibility to the other parts, i.e. the part from which the guide member 12 or the device 10 is removed.

  The cuts, slits, or grooves can be located anywhere on the guide member 12 and can be provided at various pitches to allow or provide various flexibility. One or more grooves, cuts, or slits extend partially or completely through a portion of the guide member 12. In addition, these grooves, cuts, or slits may be linear, spiral, geometric, combinations thereof, or various other configurations known to those skilled in the art, so long as they provide flexibility to the guide member 12. It is possible to have various different configurations without being limited thereto. Further, any number of grooves, cuts, or slits can be included in the guide member 12 and optionally in the portion of the expandable assembly 40. For example, the more grooves, cuts, or slits are included in the guide member 12 or a portion of the expandable assembly 40, the greater the flexibility of the guide member 12 and thus the greater the flexibility of the transport device 10. . Similarly, the depth of each groove, cutting part, and slit can be varied depending on the desired flexibility. For example, the deeper the grooves, cuts, or slits, the greater the flexibility of the guide member 12 and thus the greater the flexibility of the device 10. Furthermore, the configuration of each groove, cutting section, or slit can be varied to affect the flexibility of the guide member 12 and thus the device 10. For example, the flexibility of the guide member 12 and / or the conveying device 10 becomes less as the inner surface of a particular groove, cutting section, or slit becomes steeper.

  FIG. 1 shows an expandable assembly 40 and a stent 42 (FIG. 2) disposed at the tip 15 of the guide member 12. The expandable assembly 40 is terminated with an atraumatic tip 48. The expandable assembly 40 and the stent 42 are held at the distal end 15 of the guide member 12 by a restriction mechanism or restriction member 25. In the embodiment of FIG. 1, the actuating member 28 actuates the restricting member 25 and extends to the actuating assembly 20 located at the proximal end of the device 10. The actuating member 28 extends to the proximal end of the device 10 and is exposed so that when the clinician moves the actuating member 28 in the proximal direction, the restriction imposed by the restricting member 25 is released. ing. Alternatively, the actuation member 28 can optionally extend outside the guide member 12 to the proximal end 16 of the device 10.

  The expandable assembly 40 is connected to an expandable tube 44 that extends along the length of the guide member 12. An expandable tube 44 is used to fill the expandable balloon 46 with fluid. Fluid can be introduced through a luer lock fixture 45 positioned at the proximal end 16 of the guide member 12. In some embodiments, an expandable tube 44 may be used as a positioning member for deploying the expandable assembly 40 and stent 42. Further, the expandable assembly 40 of the device 10 is coupled to the actuation element 21 by an expandable tube 44. By sliding the actuation element 21 relative to the proximal end 16 of the guide member 12, the expandable assembly 40 can move relative to the guide member 12 and deploy from the tip 15 of the guide member 12. These and other features of the invention are described in further detail below.

  Referring now to FIG. 2, the distal end 14 of the guide member 12 has one or more struts 24 adapted to hold the expandable assembly 40 and stent 42 within the lumen 18 until deployed. Is included. Each strut 24 is biased to extend outward so that the expandable assembly 40 and stent 42 are released. Although each of the struts 24 biased to extend outward has been described, those skilled in the art will understand that it is not necessary to bias each strut 24 to extend outward.

  One or more struts 24 can be formed using a variety of different processes. For example, the process may include a machining process performed using a laser, or hydro-machining, grinding, end mill, grinding saw, polishing saw, electric discharge machine, and combinations thereof. It can include, but is not limited to, conventional machining processes that are not limited, or other machining processes that can generate sufficient slots or slits to form one or more struts 24. In the embodiment of FIG. 2, each strut 24 can be formed integrally with the guide member 12. In other embodiments, one or more struts 24 are formed as part of a separate strut assembly attached to guide member 12.

  A regulating member 25 is disposed around the support column 24. In the embodiment of FIG. 2, the regulating member 25 is a sleeve 26. The sleeve 26 is adapted to hold or maintain the strut 24 in a regulated or closed state so that the combination of the sleeve 26 and strut 24 causes the expandable assembly 40 and the stent 42 to enter the lumen 18. Retained. The sleeve 26 is adapted to cooperate with the outside of the guide member 12 so that the sleeve 26 can be displaced proximally to release the strut 24. In this exemplary configuration, the struts 24 are biased to extend outward, and when the sleeve 26 is moved proximally, the struts 24 extend outward to release the expandable assembly 40 and the stent 42. The

  The sleeve 26 can be made from various types of materials as long as the sleeve 26 can securely hold the post 24. For example, the sleeve 26 may be low density polyethylene (LDPE), polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), polyethylene (PE), polyurethane (PU), silicone tubing, and other It can be made from heat shrink synthetic materials including, but not limited to, suitable polymers or synthetic materials.

  The actuation member 28 extends from the sleeve 26, is disposed along the outside of the guide member 12, and passes through the opening 30 of the guide member 12. The actuation member 28 continues to advance along the lumen 18 of the guide member 12 until the proximal end 16 of the guide member 12 is reached. It will be appreciated that in other embodiments, the actuating member 28 may remain disposed outside the lumen 18 of the guide member 12.

  The actuating member 28 can be made of various materials and can have various configurations as long as the function of displacing the sleeve 26 can be exhibited. For example, the actuating member 28 can be fabricated from plastic, polymer, metal, composite, alloy, synthetic material, and combinations thereof.

  As shown in FIG. 2, the expandable assembly 40 includes an expandable balloon 46 attached to an expandable tube 44. The expandable tube 44 extends from the distal end 14 of the guide member 12 to the proximal end 16 of the guide member 12. The expandable tube 44 may include a plurality of holes 50. Each hole 50 and / or multiple holes 50 together form a flow path to the interior 52 of the expandable balloon 46. As such, fluid flows along the lumen 54 of the expandable tube 44 into the expandable balloon 46. To regulate such fluid flow, the atraumatic tip 48 seals the distal end of the expandable tube 44. In addition to providing a flow path to the inflated inflatable balloon 46, the hole 50 also provides a flow path to the deflated inflatable balloon 46 or removes fluid to the deflated inflatable balloon 46. Each hole 50 may have various shapes as long as fluid can be passed through each hole 50.

  In some configurations, the expandable tube 44 supports the expandable balloon 46 and the stent 42 on the inside. The expandable tube 44 can be fabricated from Nitinol, steel, metal, metal alloy, composite, plastic, and combinations thereof. Further, the expandable tube 44 can be covered with a variety of different coatings, such as, but not limited to, one or more coatings that improve lubricity and antithrombogenic properties and reduce platelet aggregation. Other coatings include, but are not limited to, hydrophilic coatings, heparinized coatings, polytetrafluoroethylene (PTFE) coatings, silicone coatings, or combinations of the coatings described herein.

  The expandable tube 44 can have a variety of different configurations and embodiments. In another embodiment, the expandable tube 44 includes a proximal end that connects the expandable tube 44 to an inflation device with an annular clamping device, such as a touhy-borst adapter. Alternatively, as shown in FIG. 1, the proximal end of the expandable tube 44 takes the form of a luer fixture, either the male or female portion of the luer fixture.

  Atraumatic tip 48 is attached to the distal end of the expandable tube 44. An atraumatic tip 48 is disposed within the lumen 54 of the expandable tube 44 to seal the expandable tube 44 and prevent fluid from escaping therefrom while the expandable balloon 46 is inflated and deflated, It also provides a flexible tip that assists in positioning and carefully advancing the delivery device 10 within the tortuous structure within the patient's body. In the illustrated embodiment, the expandable tube 44 extends to the distal end of the expandable balloon 46 and the atraumatic tip 48 is disposed therein. Alternatively, the expandable tube 44 can extend to a position proximate the distal end of the expandable balloon 46, and then a portion of the atraumatic tip 48 can be extended from the distal end of the expandable tube 44 to the expandable balloon 46. Extends to a position distal to the distal end of the. Further, in another alternative embodiment, the distal end of the expandable tube 44 is in a lumen formed in the atraumatic tip 48.

  Atraumatic tip 48 includes a core 56 surrounded by a flexible coil 58. As shown, the flexible coil 58 terminates at the distal end of the tip 48 with atraumatic portions such as solder balls and other mechanisms that form the atraumatic distal end of the tip 48. More generally, the atraumatic tip 48 can have a variety of other configurations as long as the atraumatic tip is flexible and optionally moldable. Furthermore, the atraumatic tip 48 can be positioned if the delivery device 10 is carefully advanced, while the physician or clinician uses a suitable device such as a fluoroscope or an x-ray device to insert the tip 48. In order to be able to observe the position, it may be one that does not transmit radiation. Materials that promote or provide radiopacity include platinum, alloys of platinum, gold, or combinations thereof, metals, alloys, plastics, polymers, synthetic materials, combinations of these, or appropriate materials that are not transparent to radiation. Other materials that provide a signature, including but not limited to materials that can be molded by a physician or clinician. Alternatively, the tip 48 may be a polymer immersed in or coated with a suitable radiopaque material such as, but not limited to, barium sulfate, bismuth subcarbonate, titanium dioxide, or combinations thereof.

  Referring now to FIG. 3, the distal end 14 of the delivery device 10 with the sleeve 26 disposed proximally is shown. In this exemplary configuration, the expandable assembly 40 and the stent 42 can be deployed from within the lumen 18 because the struts 24 are biased to spread outward. Deployment of the expandable assembly 40 and stent 42 places the guide member 12 in the proximal direction, places the expandable tube 44 in the distal direction, or expands with the guide member 12 in the proximal and distal directions. This can be done by combining the movements of the tubes 44.

  Referring now to FIG. 4 a, the delivery device 10 in a deployed form is shown schematically, with the expandable assembly 40 and stent 42 deployed in a lesion 70 in a body lumen 72. Deployment of the expandable assembly 40 and stent 42 can be accomplished by manipulating the actuation assembly 20 (FIGS. 1 and 2). After deploying the expandable balloon 46 and stent 42 to a desired location, such as a location adjacent to the lesion 70, fluid can be introduced through the lumen 54 of the expandable tube 44, thereby expanding the expandable balloon 46, and thus As shown in FIG. 5, the stent 42 can be deployed or pushed around the body lumen 72 and lesion 70.

  Various configurations of stent 42 are known to those skilled in the art. For example, a stent that can automatically expand under the pressure of the expandable balloon 46 can be used. In another configuration, a self-expanding stent as shown by the dotted line in FIG. 4b can be used. The self-expanding stent automatically expands by removing the restriction force applied by the struts 24 and / or the restriction member 25 and moving the guide member 12 proximally relative to the stent. In this case, the self-expanding stent surrounds the expandable balloon 46 as shown in FIG. 4b, or the stent moves the expandable balloon 46 closer to the stent, as shown by the dotted line labeled 46b. The expandable tube 44 can be surrounded while being positioned in the lateral direction and still attached to the expandable tube 44. Various stents can be used with the present invention as long as the size of the stent can be reduced to surround the expandable balloon and as long as the stent can be placed within the guide member 12 of the delivery device 10.

  Referring now to FIG. 6, an exemplary embodiment of an actuation assembly 20 that can be used to deploy the expandable balloon 46 and stent 42 is shown. By manipulating the actuation assembly 20, the expandable assembly 40 and the stent 42 are released from the restricted configuration at the distal end 14 of the guide member 12. More particularly, the expandable balloon 46 that forms part of the expandable assembly 40 can be deployed with a stent 42 disposed substantially around the expandable balloon 46.

  As shown, the actuation member 20 includes an actuation element 21 coupled to the proximal end of the expandable tube 44. Actuating element 21 includes a distal end 74 attached to and configured to cooperate with proximal end 16 of guide 12. The proximal end 76 of the actuation element 21 is attached to the proximal end of the expandable tube 44, while the proximal end of the actuation member 28 passes through the opening 47 of the sealed actuation element 21. In this exemplary embodiment, the proximal end of the expandable tube 44 includes a luer fixture 45 capable of attaching various complementary luer fixtures. For example, the luer fixture 45 is fitted with a syringe (not shown) for introducing and removing fluid from the expandable balloon 46 (FIG. 5) while the expandable balloon 46 is inflated and deflated. can do. Although the use of luer fitting 45 has been described, those skilled in the art will appreciate that various other fitting configurations can be attached or formed to the proximal end of the expandable tube 44.

  Actuating element 21 is adapted to displace distally to deploy expandable assembly 40 and stent 42. To assist in positioning the actuating element 21, the distal end 74 can have a step configuration and includes a protrusion 78 that fits into a complementary recess 80 formed in the proximal end 16 of the guide member 12. Can do. Protrusions 78 and indentations 80 indicate the relative position of expandable assembly 40 and stent 42 relative to distal end 14 of guide member 12. Accordingly, the actuation element 21 and / or the guide member 12 may include one or more protrusions and depressions. When the actuating element 21 is displaced in the distal direction, the projection 78 fits into the recess 80. To seal the lumen 18 of the guide member 12, the projection 78 is surrounded by one or more seals 84. Further, one or more seals (not shown) can surround the expandable tube 44 and / or the actuation member 28. By way of example, each sealant may be one or more O-rings fitted in one or more grooves, one or more O-rings, a gasket, or a viscous fluid sealant.

  When the actuating element 21 is displaced in the distal direction, the distal end 74 contacts a wall surface or stopper 82 formed on the guide member 12, and the actuating element 21 cannot be further displaced in the distal direction. With this arrangement, the actuating element 21 cannot be displaced excessively in the longitudinal direction towards the distal end. This stoppage of the longitudinal displacement of the actuating element 21 means that the expandable balloon 46 and the stent 42 have been deployed from within the lumen 18 of the guide member 12 to the desired position, thereby expanding or implanting the stent 42. It is shown that.

  Although one approach for indicating a particular positioning of the stent 42 has been described, those skilled in the art can identify a variety of different embodiments. For example, a plurality of indentations and / or protrusions can be included within the actuation element 21 and guide member 12 to control the distance by which the actuation element 21 and thus the stent 42 is displaced. In another configuration, a wall or stopper formed on the actuation element 21 can be fitted to the distal end of the guide member 12 to prevent excessive displacement in the longitudinal direction towards the distal end. In yet another configuration, a combination of one or more wall surfaces or stoppers of the actuating element 21 and the guide member 12 may be used. In yet another configuration, the distal end 74 of the actuation element 21 can be tapered to cooperate with a taper formed at the proximal end 16 of the guide member 12. The complementary taper controls the longitudinal displacement of the actuation element 21 relative to the proximal end 16 of the guide member 12. In yet another configuration, a combination of depressions, protrusions, wall surfaces, stoppers, threads, or tapers can be used. Various other approaches are known for controlling the distance traveled by the actuation element 21 while indicating the position of the stent 42.

  In addition to the above, the actuating element 21 may include one or more such that a wall or stopper 82 and a recess 80 are formed in a separate element or member attached or coupled to the proximal end 16 of the guide member 12. It can be understood that elements may be included. In this way, the actuating element 21 can be manufactured separately from the guide member 12, thereby reducing the cost and expense of manufacturing the proximal end 16 of the guide member 12 to the desired configuration. be able to.

  7 to 24 show alternative embodiments relating to the restriction mechanism 25. It will be appreciated that many features of the transport apparatus shown in FIGS. 7-24 are substantially similar in structure and function to the transport apparatus 10. Accordingly, the features and functions of one embodiment of the present invention are applicable to other embodiments of the present invention.

  Referring now to FIGS. 7 and 8, another exemplary embodiment of the transport apparatus 100 of the present invention is shown. As shown, the guide member 112 may be similar to other guide members described herein, extending from the distal end 114, the proximal end (not shown), and the distal end 114 to the proximal end. It has a lumen 118. The distal end 115 of the guide member 112 includes a plurality of struts 124, for example, two or more struts. Each strut 124 may optionally be biased so that the distal end of each strut 124 moves outward relative to the longitudinal axis of the guide member 112 when each strut 124 is released from the restricting member 125. it can. Although each of the struts 124 has been described as being energized, those skilled in the art will appreciate that one or more of the struts 124 can be energized.

  As shown in FIG. 8, at least one support column indicated by reference numeral 124 a is biased toward the longitudinal axis of the guide member 112. As can be seen more clearly in FIG. 7, atraumatic tip 148 is disposed on strut 124a. The atraumatic tip 148 may be moldable by a physician or clinician prior to insertion into the body lumen, either alone or in combination with the post 124a. In this way, the physician or clinician can guide the guide member 112 into a tortuous structure within the patient's body, for example, a “J” shape or the like, but not limited thereto. Chip 148 can be constructed. All or part of the atraumatic tip 148 is platinum, platinum alloy, radiopaque material, material immersed in or coated with radiopaque material, metal, alloy, plastic, polymer, synthetic material, etc. Or other materials that can be molded by the physician or clinician, either alone or in combination with the strut 124a, while providing an appropriate radiopaque signature. In this configuration, the atraumatic tip 148 can function as the atraumatic tip of the delivery device 100, so that the guidewire connected to the expandable assembly can be connected to the distal end of the guidewire that is optionally flexible. It can be placed in lumen 118 with a traumatic tip.

  In order to maintain the support column 124 in the restricted position, that is, to prevent it from spreading outward from the guide member 112, the support member 124 is surrounded by the restricting member 125. The restriction member 125 and other restriction members or mechanisms described herein are examples of means for applying a restriction force to one or more struts, or means for applying a restriction force to the distal end of the guide member. is there. In this embodiment, the restriction member 125 can extend completely or partially from the distal end to the proximal end of the guide member 112. For example, the restricting member 125 can substantially surround only the struts 124 or can have a configuration similar to that shown in FIGS.

  7 and 8, the restricting member 125 or the means for applying the restricting force is the catheter 127, which applies a force to the strut 124 to prevent the strut 124 from spreading outward or to the strut 124. A force is applied to maintain the expandable assembly 140 and the stent 142 within the lumen 118. By displacing the guide member 112 relative to the catheter 127 or displacing the catheter 127 relative to the guide member 112, the force applied to the strut 124 is removed, and in some configurations, the distal end of the strut 124 Is moved outward to deploy the expandable assembly 140 and the stent 142.

  As described above, the catheter 127 can extend completely or partially along the length of the guide member. In another configuration, the catheter 127 can be replaced with a sleeve or other structure that extends completely or partially from the distal end toward the proximal end of the guide member 112. These alternative configurations are also means for applying regulatory power as described herein. Such a restriction member or mechanism may be impermeable to radiation or includes one or more radiopaque markers that assist in positioning the device. In addition, these restricting members or mechanisms may be actuating members and / or actuating elements disposed outside the guide member, within the guide member lumen, or partially within the guide member lumen and partially outside the guide member. By using the assembly, it can slide relative to the guide member. The actuation assembly may be similar in structure and function to the actuation assembly 20 shown in FIG. 6 or any other actuation assembly described herein. Accordingly, the systems, methods, and devices of the present invention optionally include a catheter, sleeve, band, or specification to perform the desired function of regulating the distal end of one or more struts or guide members. Other structures described in the book can be used interchangeably.

  9 and 10 show another embodiment of the transport apparatus 200 of the present invention. As shown, the delivery device 200 includes a guide member 212 having a plurality of struts 224 disposed at the distal end 214. The strut 224 is maintained at the restriction position using the restriction member 225. In this embodiment, the regulating member 225 is a sleeve 226 that surrounds the column 224. The sleeve 226 acts as a restricting member or mechanism that applies force to the struts so that the struts do not spread outward or to maintain an expandable balloon and / or stent within the lumen.

  The strut 224 maintains the expandable assembly 240 and stent 240 within the lumen 218 of the guide member 212 when in the restricted position. One or more actuating members 228 are disposed within the sleeve 226 or between the sleeve 226 and the guide member 212. The actuating member 228 optionally forms part of a restricting mechanism or member, and is attached to the guide member 212 at a position indicated by the symbol A proximate to the proximal end of each strut 224. Actuation member 228 extends distally from the distal end of sleeve 226 and further extends proximally through the outside of sleeve 226 and terminates at the proximal end (not shown) of device 200. One end of each actuating member 228, whether it forms part of the sleeve 226, is attached to the sleeve 226, is attached to the guide member 212, or some combination thereof. By displacing the actuating member 228 in the proximal direction, the actuating member 228 preferentially separates the sleeve 226 into one or more portions 232 as indicated by the dotted lines. To do. By doing so, the column 224 is released as shown in FIG.

  To actuate the actuating member 228, the proximal end (not shown) of the actuating member 228 extends to the proximal end (not shown) of the guide member 212 without passing through or through the lumen 218 of the guide member 212. . Actuating member 228 includes, but is not limited to, the actuating assembly of FIG. 6 and other actuating assemblies described herein and understood by those skilled in the art in light of the teachings contained herein. It can extend to the actuating element (not shown) of the actuating assembly. The actuating member 228 can be displaced proximally relative to the guide member 212. By doing so, the restrictive force applied by the sleeve 226 is released, the strut 224 expands outward, and the expandable assembly 240 and / or stent 242 deploys.

  The sleeve 226 may be formed from a variety of different materials as long as the material from which it is made is strong enough to secure the strut 224 while being configured to preferentially separate by the action of the actuating member 228. it can. For example, the sleeve 226 includes, but is not limited to, low density polyethylene (LDPE), polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), fluorinated ethylene propylene, polyethylene (PE), polyurethane (PU) or silicone tubing. It can be made from heat shrink synthetic materials that are not.

  The one or more actuating members 228 may be proximal without damaging the actuating member 228, such as, but not limited to, the actuating assembly disclosed herein. It can be made from a variety of different materials as long as it is strong enough to be displaced in the direction. For example, the actuating member 228 can be fabricated from plastic, polymer, metal, composite, alloy, synthetic material, and combinations thereof.

  Instead of using the actuating member 228, embodiments of the present invention can use various other means for preferentially separating the sleeve 226. For example, the sleeve 226 provides a soluble chemical bond that dissolves by a chemical reaction with a fluid in the body lumen in which the delivery device is located, or resistive heating, ultrasound, or radio frequency energy, the actuating member 228 and / or A region within the body lumen in which the device 200 is contained, in particular a material that has a weaker strength than the other regions or zones of the sleeve, or a bond that breaks when applied to a cutting region or zone, or a combination thereof be able to.

  Referring now to FIGS. 11-14, an embodiment of a transport device 300 having another embodiment of a restricting member or mechanism 325 is shown. In this embodiment, the restriction member 325 is a sleeve adapted to surround the one or more struts 324 of the guide member 312 and apply a restraining force to the struts 324, thereby maintaining the struts 324 in a regulated state. It takes the form of 326. The sleeve 326 includes a first surface 364 and a second surface 366 with the first and second surfaces 364, 366 separated by an intermediate portion 368. The intermediate portion 368 surrounds the guide member 312 such that a portion of the intermediate portion 368 contacts the guide member 312 or is juxtaposed with each other, continuous with each other, or adjacent to each other. . The actuating member 328 passes through a portion of such an intermediate portion 368 and secures the sleeve 326 to the guide member 312. To further assist in applying a restrictive force to the support post 324, the first surface 364 and the second surface 366 are folded over and attached to respective portions of the outer surface of the sleeve 326.

  The process of forming the regulating member or mechanism of FIG. 11 is shown in FIGS. Referring first to FIG. 12, an open sleeve 326 is shown prior to coupling the actuating member 328, but the sleeve 326 can be formed directly on the surface of the guide member 312 or can be a separate tubular member. After being formed on the surface, the guide member 312 can be attached or bonded. Although the sleeve 326 is shown having a generally polygonal shape, those skilled in the art will appreciate that the sleeve 326 may have various other configurations as long as it can perform the functions described herein. Can understand good. In this exemplary configuration, sleeve 326 is coupled directly to guide member 312. As shown in FIG. 13, the first surface 364 and the second surface 366 of the sleeve 326 are at least one of the guide members 326 until a portion of the intermediate portion 368 is proximate another portion of the intermediate portion 368. Wrap around the part. Alternatively, the first surface 364 can be in contact with the second surface 366 or juxtaposed with the second surface 366 and can be continuous or adjacent.

  When portions of the intermediate portion 368 are in close proximity to each other, an actuating member 328 or other actuating member stitches the respective portions of the sleeve 326 and couples those portions of the intermediate portion 368 as shown in FIG. To do. When the actuating member 328 is pulled substantially straight or otherwise positioned through the sleeve 326, each of the first end 364 and the second end 366 bend, as shown in FIG. And attached to the outer surface of the sleeve 326, respectively.

  In an alternative configuration, as shown in FIG. 14, the sleeve 326 may include a plurality of openings 360 that receive the actuation member 328 in a portion of the intermediate portion 368. In this manner, the actuating member 328 can pass through the opening 360 instead of sewing the sleeve 326. In another embodiment, the first end 364 of the sleeve 326 is attached to the second end 364 of the sleeve 326 without attaching the first end 364 or the second end 366 to the outer surface of the sleeve 326. Can be combined. In yet another configuration, a portion of the first end 364 can overlap the second end 366, or vice versa. Alternatively, the first end 364 and the second end 366 are brought into contact with each other but do not overlap. Similarly, the first end 364 and the second end 366 can be adjacent to each other, adjacent to each other, continuous to each other, or juxtaposed to each other.

  To operate the restricting member or mechanism described with respect to FIGS. 11-14, the proximal end of the actuating member 328 is moved into the guide member 312 lumen or without passing through the lumen to the proximal end of the guide member 321. extend. By displacing the actuating member 328 proximally relative to the guide member 312, or vice versa, or in combination, the actuating member 328 is disposed through at least a portion of the sleeve 326. It is released from the state. In this way, the restraining force applied by the sleeve 326 is released, the strut 324 spreads outward, and the expandable assembly and / or stent is deployed. The clinician or physician can begin to move the actuating member 328 longitudinally, either directly or by using an actuating mechanism or device.

  The sleeve 326 can be formed from a variety of different materials as long as the material is strong enough to regulate one or more struts 324. For example, the sleeve 326 is made of heat shrinkable plastic or polymer, low density polyethylene (LDPE), polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), polyethylene (PE), polyurethane (PU), It can be made from various types of polymers or silicone films, including but not limited to silicone tubing.

  Actuating member 328 varies in variety as long as the material used is strong enough to displace the member proximally without damaging actuating member 328 in the actuating assembly disclosed herein. It can be formed from a material. For example, the actuating member 328 can perform or function to be placed through a plastic, polymer, metal, composite, alloy, synthetic material, combination thereof, or sleeve 326, or the like. It can be made from any material.

  Referring now to FIGS. 15-19, another embodiment of a transport device 400 having an alternative configuration of a restricting member or mechanism is shown. This particular embodiment utilizes a restricting member or mechanism 425 having a hinge configuration with an actuating member 438, which hinge configuration optionally forms part of the restricting member or mechanism 425 and the guide member. It acts as a pin for maintaining the hinge portion of the restricting member so as to hold or restrict a part.

  As shown in FIG. 15, the restricting member 425 is a sleeve 426 having a plurality of channels 464a-464f adapted to receive the actuating member 428. Both the first surface 466 and the second surface 468 of the sleeve 426 are in a number of channels 464a-464f, i.e. the channels 464a, 464c and 464e of the first surface 466 and the channel 464b of the second surface 468. 464d and 464f. By passing the actuating member 428 sequentially through the channels 464a-464f such that the actuating member 428 passes through the channel of the second surface 468 after passing through the channel of the first surface 466, the first surface 466 is The sleeve 426 applies a regulating force to the column 424 of the guide member 412.

  An exemplary process for forming the restriction member or mechanism of FIG. 15 is shown in FIGS. Referring first to FIG. 16, the sleeve 426 is shown in an open position prior to coupling the actuating member 428, and the sleeve 426 includes several extensions or tongs 460a-460f. These extensions 460a-460f are configured to form channels 464a-464f and surround a tubular member or tube, such as, but not limited to, a guide member 412 with an actuation member 428 positioned therein. The

  To attach the sleeve 426 to the guide member 412, the sleeve 426 is positioned at a desired position of the guide member 426. As shown in FIGS. 17 to 19, the operating member 428 is disposed in the state of being close to the guide member 412. The ends of the extension portions 460a to 460f are inserted between the guide member 412 and the operation member 428 as shown in FIG. Alternatively, the ends of the extensions 460a-460f can be partially wrapped around the guide member 412, and the actuating member 428 can be placed in contact with these partially wrapped extensions 460a-460f.

  After the extensions 460a-460f are tightly wrapped around the guide member 412 and the actuating member 428, the ends of each extension 460a-460f are folded over the actuating member 428 as shown in FIGS. Attach to outer surface of 426. In this way, channels 464a-464f are formed, and the sleeve 426 is configured to releasably restrict the slit 424 of the guide member 412 along with the actuating member 428.

  The release of the regulatory force applied by the sleeve 426 alone or in combination with the actuating member 428 can be accomplished by displacing the actuating member 428 in the longitudinal direction relative to the guide member 412 or vice versa, or vice versa. Realized by combination. Actuating member 428 is released from channels 464a-464f, and the biasing force of strut 424 expands the strut outward and deploys the expandable assembly and / or stent. Clinicians and physicians can begin to move the actuating member 428 longitudinally, either directly or by using an actuating mechanism or device.

  Referring now to FIG. 20, another transport apparatus 500 having another embodiment of the restriction member or mechanism 525 of the present invention is shown. The restricting member 525 includes a cord 529 that forms a number of hoops 564a-564n. One or more of the hoops 564a-564n is adapted to receive an actuating member 528 that is optionally part of a restricting member or mechanism 525. The actuating member 528 is disposed in the hoops 564a to 564n so that the cord 529 can apply a regulating force to the support column 524 of the guide member 512. The actuating member 528 can be removed from the hoops 564a-564n, such that the struts 524 can be spread outward to deploy the expandable assembly and / or stent. The cord 529 can be made from a metal wire, a polymer actuation member, or other material that can be manipulated to form a hoop through which the actuation member or fixation member passes. Optionally, the cord 529 is attached to the cord 520 under the influence of one or more struts, by an applied biasing force, or by the construction and / or material of the cord, hoop, and / or restricting member. Adapted to spread outward by power.

  The cord 529 can be attached to the guide member 512 and / or one or more of the struts coupled thereto via various attachment mechanisms. For example, the cord 529 may be a guide member and / or one by adhesive, mechanical fastener, fixed loop, or other technique that securely attaches the cord 529 to one or more of the guide member 512 and / or post 524. Or it can be attached to multiple columns. Alternatively, the cord 529 can be attached to the actuation member 528 and removed when the actuation member 528 is moved proximally. The clinician or physician can begin to move the actuation member 528 longitudinally, either directly or by using an actuation mechanism or device.

  Referring now to FIGS. 21-24, another transport device 600 having another embodiment of the restriction member or mechanism 625 of the present invention is shown. As shown, the guide member 612 includes a plurality of struts 624 adapted to expand outwardly to allow deployment of a stent and expandable balloon disposed within the lumen 618 of the guide member 612. The regulating member 625 regulates the support column 624. The restricting member 625 is a flexible member 627 made up of flaps 660 and 662 in one configuration. The flaps 660 and 662 extend between the gap 664 between two adjacent struts 624a and 624b and wrap around the strut 624 and have a stent (not shown) within the lumen 618, as shown in FIG. And an inflatable balloon (not shown). These flaps 660 and 662 may be two separate members that are coupled or otherwise connected to struts 624a and 624b, or a single member that is coupled to struts 624a and 624b while forming flaps 660 and 662. Good.

  Once the flaps 660 and 662 are positioned so that the column 624 is securely held, the flaps are stitched with the actuating member 628 at position 666 as shown in FIG. This actuating member 628 optionally forms part of a restricting member or mechanism, and other actuating assemblies known to those skilled in the art in light of the actuating assembly described in FIG. 6 and the teachings contained herein. And so on, but not limited thereto, and extends along the length of the transport device 600. A clinician or physician can begin to move the actuating member 628 longitudinally so that the restricting member or mechanism 625 is released, either directly or by using an actuating mechanism or device known to those skilled in the art.

  After actuating member 628 is used to join flaps 660 and 662, flaps 660 and 662 are folded back around strut 624 and the remainder of flaps 660 and 662, as shown in FIG. Attach to other parts of 612. Displacement of the actuating member 628 in the proximal direction releases the flaps 660 and 662 and deploys the stent (not shown) and the expandable balloon (not shown) as the strut 624 spreads outward.

  Referring now to FIG. 25, an exemplary embodiment of the proximal end of the delivery device 700a is shown. The features and structures discussed in other embodiments of the transport apparatus of the present invention apply to the transport apparatus 700a.

  As shown, the proximal end 716 of the guide member 712 terminates in the guide member housing 722. The guide member housing 722 can be integrally formed with the guide member 712 or can be a separate member that is coupled, connected or attached to the proximal end of the guide member 712. The proximal end 716 of the guide member 712 can be coupled to the actuation element 721 of the actuation assembly 720. The actuating element 721 is slidably engaged with the guide member housing 722. Manipulating the actuating element 721 moves the expandable tube 744 with an expandable balloon (not shown) attached. The actuating member 728 passes through an opening 786 in the actuating member 721 that is fitted with a seal (not shown) into which the actuating member 728 can slide. As described above, the opening 786 and the sealing material (not shown) allow the operator to regulate one or more support posts (not shown) disposed at the distal end 714 of the transport device 700a. (Not shown) can be released or displaced. The sealing material may be polyurethane, silicone rubber, or other materials that can seal around the actuating member 728 and that can slide the actuating member 728 therein while maintaining a fluid seal. Polymer gaskets can be included without limitation.

  The expandable tube 744 optionally has a configuration similar to the expandable tube 44 of FIG. 1 and extends from the distal end 714 of the guide member 712 through the guide member housing 722 and the proximal end of the actuation member 721. It ends at 776 and is attached there. As shown, the proximal end 776 of the actuating element 721 includes a luer fixture 745 that is adapted to cooperate with a complementary luer fixture and is attached to the distal end 714 of the guide member 712. A deployed inflatable balloon (not shown) is inflated and deflated.

  In this exemplary embodiment, an additional luer fixture 790 is formed in or coupled to the actuation member 721. Providing a Luer fixture 790 allows fluid to flow into the lumen 718 of the guide member 712, thereby introducing contrast agent into the bloodstream in the vicinity of the device as it advances through the vasculature. It becomes possible.

  Referring now to FIG. 26, an alternative configuration for the transport device 700a is shown as an exemplary transport device 700b. In this configuration, the engagement between the actuating element 721 and the guide member housing 722 can be achieved by complementary threads 792 formed in the actuating element 721 and the guide member housing 722. These complementary threads 792 allow the actuating member 721 to move longitudinally relative to the guide member housing 722 by rotational movement of the actuating element 721 or by movement parallel to the longitudinal axis of the guide member 712. Can be configured. By using threads 792, the longitudinal movement of the expandable balloon (not shown) and stent (not shown) disposed at the distal end 714 of the guide member 712 can be controlled very precisely. Can do.

  Although the use of complementary threads has been described, those skilled in the art will be able to variously controllably move the actuating element 721 relative to the guide member housing 722 in light of the teachings contained herein. It will be appreciated that other structures can be used. For example, the actuating element 721 can include a key that matches a keyway formed in the guide member housing 722, or vice versa. Furthermore, while rotational motion and motion parallel to the longitudinal motion of the expandable balloon and stent have been described, those skilled in the art will recognize various other that may allow or facilitate deployment of the expandable balloon and / or stent. The movement in the direction of can be specified. For example, the movement of the actuating element may proceed in a direction of an arbitrary angle with respect to the longitudinal axis of the guide member regardless of whether the actuating element rotates once or a plurality of times with respect to the guide member.

  As shown in FIG. 27, another embodiment of a transport apparatus 700c is illustrated. To assist movement of the actuating element 721 relative to the guide member housing 722, the actuating element 721 and the guide member housing 722 and / or the guide member 712 can include optional handles 796 and 798, respectively. These handles 796 and 798 can optionally include a gripping area adapted to cooperate with a user add-on of one or more devices. In another configuration, each of the handles 796 and 798 can have a substantially constant cross section along its length. In yet another configuration, each of handles 796 and 798 may vary in cross-sectional area along its length. In addition, although a single luer fixture 745 is shown in FIG. 27, one of ordinary skill in the art could use the transport device 700c to facilitate introduction of one or more fluids into the transport device or into the expandable balloon. It will be appreciated that one or more fittings may be included.

  FIG. 28 shows yet another embodiment of a transport device 700d, wherein the actuating element 721 is adapted to cooperate with a complementary part or structure 770 formed at the proximal end of the guide member 712. Includes a housing 760. The gear 762 includes one or more associated teeth, parts, or structures 768 that are selected by the clinician or other individual by selecting the actuator member 766 and rotating the actuator 764. Since gear 762 is rotated, it can be manipulated or rotated by actuator 764. Optionally, the actuator 764 takes one or more teeth, parts, or structures that can cooperate with the gear 762 so that the rotational movement of the actuator 764 is converted into the movement of the gear 762.

  As the actuator 764 and thus the gear 762 rotates, the complementary part 770 of the guide member 712 meshes with the teeth, parts, or structure 768 of the gear 762, causing the guide member 712 to move proximally depending on the direction of rotation of the actuator 764. Moving in the direction and / or distal direction. In this way, the expandable assembly and stent can be deployed from the distal end (not shown) of device 700d.

  In addition to moving or positioning guide member 712, actuating member 728 can also be manipulated by using slide switch 762 associated with housing 760 and actuating element 721. Actuation member 728 is coupled to leg 762 attached to switch 762, while slide switch 762 is slidably coupled to housing 760. The sliding translational movement of the switch 762 causes the actuating member 728 to move in the respective direction so that the restricting force applied by the regular member or mechanism (not shown) of the device 700c is released. Those skilled in the art will appreciate various other configurations for the actuating element 721 in light of the teachings contained herein.

  Referring now to FIGS. 29-37, various configurations of alternative embodiments of a transport apparatus according to the present invention are shown. Other described transport device features and functions apply to the discussion regarding transport devices 800a-800g. Furthermore, it will be appreciated that most of the features and functions described with respect to transport device 800a also apply to transport devices 800b to 800g, described further below. The transport device of FIGS. 29-37 illustrates various embodiments adapted to use a transport device with a guidewire. For ease of explanation, the embodiment of FIGS. 29-37 does not include an expandable assembly within the guide member and a restricting member or mechanism that restricts the stent. However, it will be appreciated that any restriction member or mechanism with any actuation assembly described herein or understood by one of ordinary skill in the art can be used for the devices 800a-800g.

  As shown in FIG. 29, the delivery device 800 a includes a guide member 812 having a proximal end 816 and a distal end 814 with a lumen 818 extending from the distal end 814 toward the proximal end 816. The distal end 814 can have a configuration similar to the distal ends of other guide members described herein. For example, a restricting member (not shown) may be disposed at the distal end 814 to cooperate with a structure adapted to restrict the expandable assembly 840 and / or the stent 842. Located at the proximal end 816 is a guide member housing 822 that cooperates with the actuation element 821 of the actuation assembly 820 in a manner similar to that described with respect to FIG.

  The guide wire 832 extends from the proximal end opening 834 of the actuation element 821 toward the distal end 814 of the guide member 812. As best shown in FIG. 30, guidewire 832 cooperates with expandable assembly 840 disposed at the distal end of guide member 812. In this exemplary configuration, the expandable assembly 840 includes a tubular member 836, ie, a tubular member 836 that cooperates with an expandable balloon 846 coupled or attached thereto. Tubular member 836 can function as a positioning member that facilitates deployment of expandable assembly 840 and stent 842. A guidewire 832 extends through the tubular member 836 and moves the expandable balloon 846 and the stent 842 coupled to the expandable balloon 846 along the guidewire 832 as needed. The inner diameter of the lumen of the tubular member 836 is adapted to the outer diameter of the guide wire 832.

  The guidewire 832 ends at its distal end with an atraumatic tip 848 that may include a core wire 856 around which a coil spring 858 is wound. The core wire 856 may be an extension of the remaining portion of the guidewire 832 or may be a separate member coupled or attached to the distal end of the guidewire 832. In either case, the core wire 856 can be made from the same or different material as the guidewire 832 and can optionally be a solid or tubular member.

  The expandable balloon 846 of the expandable assembly 840 is inflated by an expandable tube 844 that extends from the expandable balloon 846 and terminates at the proximal end of the actuating element 821 with a luer fixture 845. An additional luer fixture 890 can be provided attached to the actuating element 821. It will be appreciated that the luer fixture 890 can perform substantially the same function as the luer fixture 790.

  The distal end of the expandable tube 844 cooperates with the interior of the expandable balloon 846. The distal end of the expandable tube 844 can be connected to the tubular member 836, the expandable balloon 846, or both the tubular member 836 and the expandable balloon 846. During the procedure, the expandable tube 844 can be used to position the expandable balloon 846 and / or the stent 842. Thus, the expandable tube 844 can have sufficient strength to convert the distal movement of the expandable tube 844 into the distal movement of the remaining portion of the expandable assembly 840. Similarly, the expandable tube 844 can have sufficient strength to convert the proximal movement of the expandable tube 844 into the proximal movement of the remainder of the expandable assembly 840.

  The delivery device 800a is configured to allow the guide wire 832 to be positioned within the body lumen, and the delivery device 800a can be removed from the body lumen while maintaining the guide wire 832 in the desired position. Can do. Thus, other conventional interventional devices can be used to complete this procedure. As discussed in more detail below, the distal end of the guidewire can be connected to a device such as, for example, a filter assembly that collects free embolic particles within the body vessel during stenting. Other devices can be introduced into the guidewire 832 as will be appreciated by those skilled in the art.

  FIG. 31 shows another embodiment, which is apparatus 800b. The device 800b includes an expandable assembly 840b adapted to cooperate with a guidewire 832. As shown, the expandable assembly 840b includes a tubular member 836 that cooperates with an inflatable expandable balloon 846. A positioning member 838 is disposed at the proximal end of the tubular member 836. Positioning member 838 is coupled to the proximal end of tubular member 836 so that the force applied by positioning member 838 is easily transferred to tubular member 836 to position expandable assembly 840. Positioning member 838 may be coupled or attached at the proximal end, distal end of tubular member 836 and / or expandable balloon 846, or near tubular member 836 and / or expandable balloon 846, respectively. It can be coupled or attached to the tubular member 836, the expandable balloon 846, or both the tubular member 836 and the expandable balloon 846, whether it occurs elsewhere in the distal and distal ends. Similarly, coupling or attachment of the positioning member 838 to one or both of the tubular member 836 and the expandable balloon 846 leads to or against the inner surface and / or outer surface of the tubular member 836 and the expandable balloon 846. Things can be used. By doing so, the physician or clinician can manipulate the positioning member 838 to position the expandable assembly 840b in the desired position and expand the stent (not shown) and / or lesion. For example, the positioning member 838 can be used to slide the expandable balloon 846 along the guidewire 832.

  As shown, the positioning member 838 is separate from the expandable tube 844. Although a positioning member 838 separate from the expandable tube 844 has been described, the positioning member 838 can be removably disposed within the expandable tube 844, while at the same time, the expandable balloon 846 can be placed within a body lumen or vessel. It will be appreciated that the position can be For example, as indicated by the dotted line in FIG. 31, a stopper 837 extends from or is formed within the tubular member 836 to cooperate with the distal end of the positioning member 838 disposed within the lumen of the expandable tube 844. Can work. By moving the positioning member in the distal direction, the distal end of the positioning member cooperates with the stopper 837, thereby moving the expandable assembly 840b in the distal direction. To move the tubular member 836 in the proximal direction, the clinician or physician can move the expandable tube 844 in the proximal direction. In another configuration, the stopper 837 can include a recess (not shown) that frictionally fits or otherwise cooperates with the distal end of the positioning member so that the positioning member is tubular. The member 836 is held in the recess with sufficient force to move both the proximal and distal directions.

  The proximal end of the guide member housing 822 shown in FIG. 31 cooperates with the actuating assembly 821b, while the distal end 814 of the guide member 812 cooperates with a restricting member or mechanism (not shown) to expand. It is designed to help apply a regulatory force to the assembly 840b and / or the stent 842. The actuating element 821b is adapted to allow the clinician to operate the delivery device 800b and deliver the stent 842 in a manner similar to the device described in FIG. For example, the positioning member 838 can be coupled to the actuation element 821b such that the distal movement of the actuation element 821b moves the expandable assembly 840b.

  Further, the proximal end of the actuating element 821b may be in light of an annular clamping mechanism 862, such as, but not limited to, a tuffy bolster adapter, a compressible polymer, a silicone rubber gasket, or the teachings contained in the present invention. Other annular clamping mechanisms 862 known to those skilled in the art are included. Annular clamp mechanism 862 receives guidewire 832 and provides a mechanical connection and fluid seal between actuation element 821b and guidewire 832. This seal prevents fluid from escaping from lumen 818 and, when using other conventional interventional devices, guidewires without losing contact with the blood vessels obtained by the device as a whole. A mechanism is provided for releasing the transport device 800b from 832. For example, the seal is broken by rotating the annular clamp mechanism 862, and the transfer device 880 b is removed from the guide wire 832. A similar clamp or other seal can be associated with the positioning member 838 to prevent fluid from escaping from within the device 800b.

  FIG. 32 shows a transport apparatus 800c according to another embodiment. In this embodiment, tubular member 836 extends substantially between distal end 814 and proximal end 816 of guide member 812. Tubular member 836 is adapted to receive guide wire 832 therein. Thus, the tubular member 836 extends from the distal end of the expandable balloon 846 to the proximal end of the guide member 812, such that the proximal end of the tubular member 836 ends at a point near the proximal end of the expandable tube 844. ing. Further, the proximal end of the tubular member 836 cooperates with an actuating element 821c disposed at the proximal end of the guide member 812 and / or the proximal end of the guide member 812.

  The operating element 821c includes a fixed portion 829 and a movable portion 831 that is slidably disposed together with the fixed portion 829. The securing portion 829 can be integrally formed with the proximal end of the guide member 812, or can be a separate member coupled or attached to the proximal end of the guide member 812, in which case such a Bonding or attachment can be done by complementary threads, key and keyway configuration, chemical bonding, thermal bonding, or adhesive.

  The movable part 831 cooperates with the fixed part 829 in a sealed state so that the fluid that has entered the internal space defined by the inside of the fixed part 829 and a part of the movable part 831 does not escape therefrom. This sealing can be provided by one or more sealing members 833 and / or can be created between tolerances associated with the fixed portion 829 and the movable portion 831. By way of example, the sealing member 833 may be one or more O-rings, one or more O-rings, gaskets, or viscous fluid seals that fit into one or more grooves.

  The movable part 831 includes a support structure 823 extending from end to end of its distal end. The proximal end of the tubular member 836 is attached while secured to the support structure 823. Support structure 823 also includes an opening 825 through which guidewire 832 passes. Seal 827 is preferably disposed between and / or within opening 825 and guide wire 832 to retain fluid within guide member 812. Therefore, when the movable portion 831 is pressed in the direction of arrow A, the expandable balloon 846 is deployed from within the lumen 818 of the guide member 812. Similarly, by moving the movable portion 831 of the actuation element 821 c in the direction of arrow B, the expandable balloon 846 is drawn into the lumen 818 of the guide member 812.

  As shown in FIG. 33, a conveying apparatus 800d which is another embodiment is illustrated. In this embodiment, the expandable balloon 846 is directly coupled to or attached to the guidewire 832. As a result, positioning member 838 is connected to guide wire 832 and / or optionally inflatable balloon 846 instead of tubular member 836. The positioning member 838 can be manipulated by a physician, clinician, etc. to position the expandable assembly 840 in a desired position and expand the stent and lesion. As a result, the positioning member 838 can be moved to place the expandable balloon 846 in place and optionally pre-expand and / or expand the lesion while the stent 842 is implanted. .

  FIG. 34 shows a transfer apparatus 800e according to another embodiment. In this embodiment, the positioning member 838 is connected to the expandable balloon 846. The positioning member 838 can be manipulated by a physician, clinician, or other individual to place the expandable assembly 840 in a desired position to expand the stent and lesion. As a result, moving the positioning member 838 places the expandable balloon 846 in place, optionally pre-expanding and / or expanding the lesion during implantation of the stent (not shown). can do.

  Guide wire 832 passes between expandable balloon 846 and stent 842. Although not shown for ease of explanation, the guidewire 832 can have an atraumatic tip attached or formed at its distal end. The expandable balloon 846 includes an integrally formed expandable tube 844 that extends from the distal end of the expandable balloon 846. The inflatable balloon 846 can have a variety of configurations like the other inflatable balloons described herein, for example, the inflatable balloon 846 has a substantially constant cross-section along its length. The cross section may be varied along its length. Further, the inflatable balloon of the present invention can be formed from one or more separate inflatable balloons having one or more inflatable tubes associated therewith, which together are a single inflatable balloon. Demonstrate the function.

  Further, FIG. 34 shows a tip 864 disposed at the distal end of guidewire 832. Tip 864 provides a transition between guide wire 832 and guide member 812, minimizing the possibility of damaging the patient's body lumen or blood vessel during insertion and removal of delivery device 800e during the procedure. Keep it down. Various types of chips are known to those skilled in the art, including, but not limited to, those discussed herein and others known to those skilled in the art in light of the teachings contained herein. Not. For example, the tip 864 is such that the configuration provides a transition between the guide wire 832 and the guide member 812 to help prevent damage to the body lumen or blood vessel during insertion and removal of the delivery device 800e. As long as it can have various configurations. Further, the tip 864 may be attached to the guide wire 832 by various techniques such as, but not limited to, adhesives, mechanical bonds, heat generated bonds, integrally formed, or combinations thereof. Can be combined or attached.

  As shown in FIG. 35, a transfer apparatus 800f according to another embodiment is illustrated. In this embodiment, the guidewire 832 passes between the guide member 812 and the expandable assembly 840 and terminates at a location away from the distal end of the guide member 812. Although not shown for ease of explanation, the guidewire 832 can have an atraumatic tip attached or formed at its distal end. Connected to the expandable balloon 846 is a positioning member 838 similar to that described herein. The positioning member 838 is operable by a physician, clinician, or other individual to position the delivery device 800f in a desired position and expand the stent and lesion. As a result, the positioning member 838 can be moved to place the expandable balloon 846 in place and optionally pre-expand and / or expand the lesion while the stent 842 is implanted. . The transport apparatus 800f also includes a chip 864 similar to the structure and function of the chip 864 shown and discussed with respect to FIG.

  FIG. 36 shows still another embodiment of the transport apparatus of the present invention. As shown, the transport device 800g includes an expandable assembly 840g that may be similar to other expandable assemblies described herein, which is disposed beyond the distal end 814 of the guide member 812. Yes. Guide member 812 serves as a positioning member to position expandable assembly 840g in a desired position to expand the stent and lesion. As a result, by moving the guide member 812, the expandable balloon 846 can be placed in place to pre-expand the lesion and / or expand the lesion during implantation of the stent. Although not shown for ease of explanation, the guidewire 832 can have an atraumatic tip attached or formed at its distal end.

  Figures 37 to 44 illustrate another aspect of the present invention. During the procedure of expanding the lesion and / or implanting the stent in the lesion, the embolus is often released and carried downstream of the body's blood vessels. One or more embodiments of the present invention can include means for providing embolic protection so that the embolus does not block downstream of the smaller body vessels. The means for providing embolism prevention may be included in a delivery apparatus having a single configuration capable of inserting the delivery device and the means for providing embolism prevention, such as a filter device, into the body lumen substantially simultaneously. it can.

  Referring to FIG. 37, an exemplary transport apparatus 900 is shown having many of the same features and functionality as the transport apparatus described thus far. Accordingly, the descriptions of various other transport devices described herein apply to transport device 900. As shown, the delivery device 900 includes a guide member 912 having an expandable assembly 940 and a stent 942 disposed therein. In the embodiment of FIG. 37 and the following subsequent embodiments, a restricting member or mechanism indicated by a dotted line is disposed at the distal end 914 of the guide member 912 and adjacent to or near the distal end 914 of the guide member 912. It will be appreciated that these can be regulated until it is desired to deploy the expandable assembly 940 and stent 942. Any restriction member or mechanism can be used as disclosed herein or will be understood by one skilled in the art. Further, suitable structures for deploying the expandable assembly 940 and stent 942 can be used as described herein or will be understood by one skilled in the art.

  With continued reference to FIG. 37, the delivery device 900 has a filter assembly 931 disposed distally of the guide member 912. In accordance with the teachings of the present invention, the transfer device 900 has a guidewire 932 positioned through the expandable assembly 940 and optionally further through the filter assembly 931. In the illustrated configuration, guidewire 932 terminates in a filter assembly 931 that is coupled to the distal end of guidewire 932 and is atraumatic as described in more detail below. Including chips.

  Filter assembly 931 is adapted to provide embolic protection during use of device 900. As shown in FIGS. 37 and 38, the filter assembly 931 is of a low profile for ease of insertion into a body lumen. A transition member 936 is disposed between the filter assembly 931 and the expandable assembly 940. Transition member 936 is adapted to provide a transition between guide member 912 and filter assembly 931. This transition portion prevents damage to the lumen of the body in which the device 900 is located, and one or more bodies when the device 900 is carefully advanced through tortuous structures in the patient's body. It becomes uncaptured by the wall or junction of the lumen. As shown, the transition member 936 includes a passage 938 disposed therein for receiving the guide wire 932. The passage 938 can be adapted to securely hold the guide wire 932 therein or, optionally, to removably receive the guide wire 932. Alternatively, the transition member 936 can include a hole through which the guide wire 932 passes or receives the guide wire 932. In yet another configuration, the transition member 936 includes a hole adapted to receive the distal end of the guidewire 932, while the distal end of the transition member 936 is formed by the filter assembly 931 or the filter assembly. Work with 931.

  37 and 38 show the filter assembly 931 in a regulated state in preparation for deployment of the filter assembly 931, while FIGS. 39-41 show the filter assembly 931 in a deployed or activated state. As shown in FIG. 41, the filter assembly 931 includes a filter basket 934 and a filter 933. Prior to deployment, the filter 933 can be placed inside the filter basket 934, can be placed around the filter basket 934, or a combination thereof. The filter 933 is adapted to trap embolic particles or substances that may be released during the procedure associated with the delivery device 900, or, optionally, the guide wire 932 and association. Is adapted to trap embolic particles or substances that may be released during other procedures when the carrier device 900 is optionally slidably removed from the assembled filter assembly 931. . Thus, optionally, when the filter 933 is deployed, the distal end of the filter 933 floats in the body lumen and the proximal end of the filter 933 is coupled to the filter basket 934. Can float on. In another configuration, the distal end of the filter 933 can be coupled to a portion of the filter basket 934.

  Filter 933 can capture woven or braided type plastic or metal mesh, perforated polymer film, Nitinol mesh, combinations thereof, or flowing substances in the blood while at the same It can be made from a variety of different materials, such as but not limited to other materials that can be passed through the opening. Generally, the filter 933 is as long as it can be stuffed into the filter basket 934, and optionally floats in the blood flow through the body lumen into which the filter is inserted, and is biocompatible. Can be made from a variety of materials.

  Filter 933 can have a variety of different sizes of pores ranging from about 50 microns to about 200 microns, from about 60 microns to about 180 microns, or from about 75 microns to about 150 microns. For example, the holes can have a variety of different shapes such as, but not limited to, circles, polygons, combinations thereof, or other shapes known to those skilled in the art in light of the teachings contained herein. Thus, in certain configurations, the filter 933 can include holes of various sizes and shapes. Thus, the major or minor axis of each hole can have a variety of different sizes ranging from about 50 microns to about 200 microns, from about 60 microns to about 180 microns, or from about 75 microns to about 150 microns. In general, the pore size is the possibility that the pore is dimensioned so that blood flow through the filter is not impaired by the pore, i.e., does not prevent blood from passing through the filter, and occludes a narrower downstream vessel. As long as the pores are sized to collect substances that can block blood flow to the tissue or cause a stroke or infarction, it can be varied as needed.

  In addition to the above, filter 933 is known or desired by those skilled in the art in light of a hydrophilic coating, a heparinized coating, a polytetrafluoroethylene (PTFE) coating, a silicone coating, combinations thereof, or the teachings contained in the present invention. It can be coated with various other coatings.

  The filter basket 934 supports the filter 933 after the filter 933 is deployed. Filter basket 934 includes a plurality of struts 960 extending from body 962. The struts 960 of the filter basket 934 are adapted to spread outward to position the filter 933 within the body lumen. The strut 960 a of the strut 960 can include an atraumatic tip 948 that is in a state of forming at least a portion of the core of the atraumatic tip 948. This post may be covered with a flexible coil 958. The body 962 of the filter basket 934 includes a hole 967 adapted to receive a guide wire 932. Alternatively, the body 962 can include a passage adapted to receive the distal end of the guidewire 932.

  Filter 933 can be attached to column 960 of filter basket 934 in a variety of ways. For example, the filter 933 can be attached by adhesive, solvent bonding, thermal bonding, mechanical connection, or a combination thereof. Further, the distal ends of two or more struts 960 can include holes through which strands of filter media 932 can pass and attach to struts 960. Alternatively, the strands can be tied together, folded back with filter 933 and spotted on filter 933. There are various other ways to couple or connect the filter 933 to the filter basket 934.

  Optionally, filter assembly 931 includes a number of radiopaque bands and / or markers attached to various locations on filter assembly 931. For example, bands or markers that are impermeable to radiation, or other means may be included in the filter 933, filter basket 934, and / or strut 960. In other configurations, the transport device generally includes means for being radiopaque at one or more locations or positions thereof, thereby viewing the transport device and various elements and the location of those components. To help.

  As shown, a restricting member or mechanism 925 restricts the strut 960, while another restricting member, indicated by a dotted line, restricts the distal end of the guide member 912. Optionally, a restricting member or mechanism 925 restricts both the distal end of guide member 912 and strut 960. 37 and 38 show a restricting member or mechanism 925 that restricts the strut 960, while FIGS. 39-41 show the strut 960 released from the restricting member or mechanism 925. In the exemplary configuration of FIG. 41, the regulating member or mechanism 925 has the same configuration as the regulating member or mechanism 525. The restricting member or mechanism 925 thus forms a number of hoops, i.e. a number of hoops in which the one or more hoops are adapted to receive the actuating member 928, and optionally of the restricting member or mechanism 925. It includes a code 929 that is part of it. The actuating member 928 is disposed in the hoop such that the cord 929 applies a restricting force to the support column 960. Actuating member 928 can be removed from the hoop, thereby spreading strut 960 outward and deploying filter 933. The cord 929 can be made from a metal wire, a polymer actuation member, or other material that can be manipulated to form a hoop through which the actuation member or fixation member passes. Optionally, the cord 929 is directed outwardly under the influence of one or more struts, or by a biasing force applied to or incorporated into the cord 929 by the configuration and / or material of the cord, hoop, and / or restriction member It is made to spread.

  The cord 929 can be attached to one or more struts 960 of the filter assembly 931 by various attachment mechanisms. For example, the cord 929 may be attached to one or more of the guide members and / or struts by adhesive, mechanical fasteners, fixed loops, or other techniques that securely attach the cord 929 to the one or more struts 960. Can be worn. Alternatively, the cord 929 can be attached to the actuating member 928 and removed when the actuating member 928 is moved proximally. The clinician or physician can begin to move the actuation member 928 longitudinally, either directly or by using an actuation mechanism or device. Although one particular embodiment of a restriction member or mechanism 925 has been described, those skilled in the art will appreciate that other restriction members or mechanisms described herein can be used to restrict the post 960.

  As shown, the filter basket 934 includes one or more holes 970 adapted to receive at least a portion of a restriction member or mechanism 925. The holes 970 can be located at various locations on the filter assembly 931. Although not intended to be limiting, for example, the body 962 and each strut 960 can include one or more holes 970. The restricting member or mechanism 925 is at least partially 1 with the cord 929 or other portion of the restricting member or mechanism 925 optionally coupled to one of the struts 960 or the body 962 of the filter basket 934. One or more holes 970 can be placed. By moving the actuating member 928 of the restricting member or mechanism 925 in the proximal direction, the strut 960 moves outward and releases the filter 933.

  A proximal end (not shown) or actuating member 925 of the restricting member or mechanism 925 touches so that a clinician or physician can manipulate the restricting member or mechanism 925 to apply a restricting force to the post 960. It is possible. Optionally, the proximal end of the restricting member or mechanism 925 can be manipulated to move the restricting member or mechanism 925 as needed to release the restricting force applied by the restricting member or mechanism 925. Can cooperate with the actuating assembly.

  37-41, the actuating member 928 of the restricting member or mechanism 925 can be moved proximally with sufficient motion and force to disengage the cord 929 from the hoop. . By breaking the coupling or engagement between the actuating member 928 and the cord 929, the strut 960 expands or moves outward to deploy the filter 933. After filter 933 is deployed, an actuation assembly (not shown) is manipulated to deploy expandable assembly 940 and stent 942 from guide member 912 as shown in FIG. 40 in a manner similar to that described herein. To do. Thus, two actuation assemblies may be used, one that releases the restricting member or mechanism 925 and the other that releases the expandable assembly 940 and the stent 942.

  It will be appreciated that the restricting member or mechanism 925 is just one means of restricting the strut 960 of the filter basket 934. Other configurations can use the regulation configuration or regulation means shown in FIGS. 2 to 24, but are not limited thereto. For example, the column 960 of the filter basket 934 can be regulated in a similar manner as the column associated with the guide member of the present invention.

  Returning to FIG. 40, delivery device 900 is shown with filter assembly 931 deployed and expandable assembly 940 and stent 942 deployed from guide member 912. Deployment of the expandable assembly 940 and stent 942 can be accomplished in a manner similar to that described for the other expandable assemblies and stents discussed herein. Similarly, the filter assembly 931 can be deployed by manipulating the restricting member or mechanism 925 to release the column 960 and deploy the filter 933. The expandable assembly 940 and stent 942 can be released from within the guide member 912 by moving the guide member 912 relative to the guide wire 932, or vice versa, or a combination thereof.

  42 and 43 show another embodiment, a filter assembly 1031. The filter assembly 1031 has a means for regulating a column 1060 according to another embodiment. This particular strut 1060 configuration indicates that strut 1060 can be coupled or attached to the distal end of guidewire 932 or transition member 936 (FIG. 37). The length of the post 1060 can vary based on the particular configuration of the guide member 1012.

  As shown in FIG. 43, the restricting mechanism 1064 maintains the column 1060 in the restricting position. In this embodiment, the restriction mechanism 1064 includes a tubular member 1062 attached to each strut 1060 and a restriction or actuation member 1025 disposed therein. Although the tubular member 1062 attached to each strut 1060 has been described, one or more tubular members 1062 can be attached to each strut 1060 and / or a smaller number of struts 1060 each include a tubular member 1062. Will be understood.

  Each tubular member 1062 is adapted to receive a restriction or actuation member 1025. As shown in FIG. 43, when the strut 1060 is regulated, the tubular members 1062 are aligned in a row to receive the regulation or actuation member 1025. That is, each of the tubular members 1062 is staggered with other tubular members 1062 on adjacent struts 1060 so that the tubular members 1062 are aligned in a row from the proximal end to the distal end of the filter assembly 1031. become. Then, as shown in FIG. 43, a restraining or actuating member 1025 is placed through the series of tubular members 1062 to restrain the strut 1060 and prevent the strut from spreading outward.

  The restriction or actuation mechanism 1025 extends from the filter assembly 1031 into the lumen of the guide wire 1032 and terminates at the proximal end of the guide wire 1012 and optionally beyond the proximal end of the guide member 1012. Alternatively, the restriction or actuating member 1025 extends proximally from the filter assembly 1031 and exits from the opening 1069 indicated by the dotted line, and then terminates at the proximal end of the guide member 1012 and optionally further includes a guide member. Extends beyond the proximal end of 1012. In this latter configuration, the restricting or actuating member 1025 extends to the proximal end of the guide member 1012 and optionally further beyond the proximal end of the guide member 1012 so that the restricting or actuating member 1025 is attached to the guide member 1012. It can be located externally or partially outside the guide member 1012. It will be appreciated that the clinician or physician can manipulate the restricting member or mechanism 1064 to release the restricting force applied by the restricting member or mechanism 1064. Alternatively, the restriction member or mechanism 1064 may be an actuation assembly similar to that described herein, such as but not limited to the actuation assembly described with respect to FIG. 6, or any other known to those skilled in the art Can be optionally operated by an actuating assembly.

  Each tubular member 1062 coupled to the post 1060 may be fabricated from metal, plastic, polymer, polymer, synthetic material, whether the material is the same as or different from that forming the guide member 1012. it can. In one embodiment, each tubular member 1062 is a polymer tube, such as a polyimide or polyurethane tube secured to a respective post 1060 with an adhesive. In another configuration, each tubular member 1062 is a metal cut tube that can be attached to a respective post 1060 with an adhesive or solder. In yet another configuration, each strut 1060 includes an opening through which the actuating member 1025 passes so as to restrict the strut 1060 and not spread outward.

  Referring now to FIG. 44, an exemplary configuration of another filter assembly according to another aspect of the present invention is shown. A functional feature of the filter assembly 1131 is that it can be applied to other filter assemblies of the present invention, and vice versa. Further, considerations regarding one or more other struts of the filter assembly 1131 are also applicable to struts associated with the guide members of the transport apparatus of the present invention.

  As shown in FIG. 44, the filter assembly 1131 includes a body 1162 and one or more struts 1160. A filter 1133 is coupled to one or more struts 1160. Extending from the body 1162 is an atraumatic tip 1148 with an associated coil 1158 within the filter 1133. For ease of explanation, the restricting member or mechanism associated with the filter assembly 1131 is not shown, but any of the restricting members or mechanisms described herein may be used to It will be appreciated that a regulatory force can be applied to multiple struts.

  The post 1160 extends from the body 1162 of the filter assembly 1131. Although the specification describes a post 1160 integrally formed with the body 1162, it will be appreciated that the post 1160 may be a separate member coupled to the body 1162. Further, the strut 1160 can be integrally formed with a guide wire 1132 or can be a separate member coupled to the guide wire 1132.

  Each strut includes a distal portion 1162, a proximal portion 1166, and an intermediate portion 1164 disposed between the distal portion 1162 and the proximal portion 1166. The strut 1160 may be attached to the filter 1133 either outside the filter 1133 or inside the filter 1133, along the edge of the filter 1133, through the filter 1133, or by a combination of one or more processes. To add additional surface area to connect each strut 1160 to the filter 1133, the strut 1160 can be configured such that the cross-sectional dimension of the distal portion 1162 is larger than the middle portion 1164. In other words, the surface area of the distal portion 1162 can be greater than the surface area of the intermediate portion 1164. The wide cross-sectional area provided by the cross-sectional dimensions of the distal portion 1162 can provide a wider area for coupling each strut 1160 to the filter 1133. In this configuration, a strong bond is created between each strut 1160 and the filter 1133.

  Similarly, each strut 1160 is such that the cross-sectional dimension of the proximal portion 1166 is larger than the intermediate portion 1164 and, at the same time, optionally, the cross-sectional dimension of the proximal portion 1166 is similar to the distal portion 1162. It can be configured to be larger, smaller or smaller. By increasing the cross-sectional dimension, that is, by increasing the surface area, each strut 1160 can apply a greater biasing force to spread the strut 1160 outward and deploy the filter 1133.

  The degree of bias applied by each strut 1160 to move the distal portion 1162 toward the vessel wall by changing the cross-sectional area of the distal portion 1162, the intermediate portion 1164, and / or the proximal portion 1166. Can be changed. The biasing force can also be changed by optionally changing the length of each strut 1160 and / or changing the curvature of each strut 1160.

  Although the present description has described the case where each of the struts 1160 has the above-described configuration, those skilled in the art will appreciate that one or more struts 1160 can be configured as described above. Further, each strut 1160 can optionally be configured separately so that each strut 1160 can have a similar or different biasing force compared to other struts 1160 of the same transport device. By varying the biasing force, the delivery device can be used for a variety of different procedures or vascular structures.

  The strut 1160 can be formed from Nitinol, stainless steel, metal, alloy, composite, plastic, polymer, synthetic material, or combinations thereof. Each strut 1160 can have a generally straight distal portion 1162, a proximal portion 1166, and / or an intermediate portion 1164. Alternatively, each strut 1160 can have a generally curvilinear distal portion 1162, a proximal portion 1166, and / or an intermediate portion 1164. In yet another configuration, each strut 1160 can have a combination of one or more straight portions and / or one or more curved portions.

  Atraumatic tip 1148 is coupled to body 1162, such as within a lumen or hole 1137. The atraumatic tip 1148 can include a core wire 1156 and a flexible coil 1158 disposed on the surface thereof. Core wire 156 passes through opening 1170 at the distal end of filter 1133. Alternatively, the core wire 1156 passes through one or more holes formed in the filter 1133. In order to secure the filter 1133 to the atraumatic tip 1148, a stationary coil 1186 surrounds a portion of the coil 1158 and the distal end of the filter 1133. While this is one way to connect the filter 1133 to the atraumatic tip 1148, those skilled in the art will recognize various other ways to connect the filter 1133 to the atraumatic tip 1148. For example, the distal end of filter 1133 may be atraumatic using adhesives, mechanical fasteners, clamps, seals, friction fits, pressure fits, or other techniques that connect filter 1133 to atraumatic tip 1148. The chip 1148 can be coupled. In another configuration, the filter 1133 is not connected to the atraumatic tip 1148 but is slid along a portion of the atraumatic tip 1148.

  Referring now to FIGS. 45 and 46, two exemplary embodiments of a capture device or mechanism that can be used to capture the filter of the filter assembly are shown. After deploying the filter, it is preferable to capture the filter after performing a stent operation. More specifically, it is desirable to capture and remove the embolic particles captured by the filter.

  FIG. 45 illustrates a capture device 1200 according to one aspect of the present invention. Capture device 1200 includes a capture catheter 1202. As shown, the capture catheter 1202 includes a capture portion 1204 and a positioning member 1206 connected to or attached to the capture portion 1204. The capture portion 1204 has a distal end 1208 and a proximal end 1210. The capture portion 1204 includes a lumen 1212 that extends from the distal end 1208 and terminates in an opening 1214 at its proximal end 1210. The distal end 1208 optionally includes one or more radiopaque markers or bands 1216, only one of which is shown. Similarly, the proximal end of positioning member 1206 can include one or more radiopaque markers or bands 1216. More generally, any of the capture and transport devices and guidewires of the present invention can include one or more radiopaque indicators, which can be markers, bands, studs, etc. Or other radiopaque display elements.

  Lumen 1212 is configured to receive a guidewire with a delivery device filter assembly (not shown) attached thereto. In one embodiment, the lumen 1212 can include a member 1218 having a stopper member 1218, shown in dotted lines, having a hole 1220 therethrough. A guide wire indicated by a dotted line with reference numeral 1232 passes through the hole 1220 of the stopper member 1218. The guidewire 1232 can have a variety of configurations, including but not limited to those described herein and others known to those skilled in the art.

  Stopper member 1218 may guide the guide wire 1232 after the capture catheter 1202 has fully received within the lumen 1212 the filter assembly coupled to the guide wire 1232 so that the filter of the filter assembly is at least closed so as not to allow embolic material to escape. Prevents the filter assembly located at the distal end of the tube from passing through the hole 1220. In some configurations, the filter assembly and the combined filter are completely encapsulated in the capture portion 1204 of the capture device 1200. In other configurations, the filter assembly and / or filter is partially encapsulated by the capture portion 1204 of the capture device 1200. Those skilled in the art will appreciate various other configurations of the stopper member 1218 as long as the filter assembly coupled to the guidewire 1232 and / or filter capture is fully or partially facilitated by the stopper. .

  Positioning member 1206 is attached to capture catheter 1202 and can be used to move capture catheter 1202 along guidewire 1232, but such movement can cause catheter 1202 to move relative to guidewire 1232. It may be caused by movement, or it may be that the guide wire 1232 is moved relative to the catheter 1202, or a combination thereof. The positioning member 1206 is sufficiently rigid so that the force applied to the proximal end 1224 is translated into longitudinal movement of the capture portion 1204 of the capture catheter 1202. In some configurations, the positioning member 1206 is a solid member, while in other configurations, the positioning member 1206 is partially or completely hollow. The positioning member 1206 can be made from a polymer, plastic, polymer, synthetic material, metal, alloy, combinations thereof, or other materials that can be used in medical devices and have the required stiffness.

  As shown in FIG. 46, an alternative embodiment of a capture device 1300 is shown. As shown, the capture device 1300 takes the form of a tubular member, which can be completely hollow or partially hollow along its length. The capture device 1300 includes a capture portion 1304 disposed at the distal end 1308. Lumen 1312 extends between distal end 1308 and a location proximal to distal end 1308 and terminates in opening 1326. In one embodiment, the location of the opening 1326 coincides with the proximal end of the lumen 1312 such that the lumen 1312 extends from the proximal end 1310 of the capture device 1300 to the distal end 1308. Opening 1326 is adapted to receive guidewire 1332 in a manner similar to opening 1214 of FIG. Lumen 1312 is configured to receive a filter assembly of a delivery device (not shown). More specifically, lumen 1312 fully or partially receives a filter assembly and / or filter coupled to guidewire 1322.

  The capture portion 1304 is configured so that the filter assembly of the transport device does not pass through. In this exemplary configuration, the length of lumen 1312 is optionally configured so that capture portion 1304 does not travel beyond the filter assembly and / or its filter. In other configurations, the lumen 1312 can travel over the filter assembly and / or filter beyond what is needed to capture it. In another configuration, the lumen 1312 may include a stopper member similar to the stopper member 1218 discussed herein. Further, the capture portion 1304 may include one or more radiopaque markers disposed at its distal and proximal ends and / or similar to the marker 1216 disposed between its distal and proximal ends. Can optionally be included.

  Thus, in general, embodiments of the present invention provide a single device that can be inserted into a body lumen together with the functionality of a guidewire, stent delivery device, expandable balloon, embolic protection device, or subsets thereof. Integrated systems, methods, and devices can be provided. Thus, embodiments of the present invention reduce the number of devices required to perform a procedure, reduce the time required to perform a procedure, and reduce the difficulty and complexity of the procedure, thereby It enables safe treatment and increases the effectiveness for patients.

  The various delivery devices and associated expandable assemblies, stents, guide members, actuator assemblies, guide wires, filter assemblies, and other element portions of the present invention can be used interchangeably. Accordingly, the statements regarding one transport device and associated components and / or elements are also applicable to other transport devices described herein and other devices known to those skilled in the art in light of the disclosure herein. It is.

  The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing. All changes that fall within the scope of the claims and their equivalents are embraced within the scope of the invention.

1 is a perspective view of an exemplary stent delivery device according to one aspect of the present invention. FIG. FIG. 2 is a side cross-sectional view of the distal end of the device of FIG. FIG. 2 is a cross-sectional side view of the distal end of the apparatus of FIG. 1 with the distal end in an unrestricted position. FIG. 2 is a cross-sectional side view of the distal end of the device of FIG. 1 with the deployed expandable assembly. FIG. 2 is a cross-sectional side view of the distal end of the device of FIG. 1 with the deployed expandable assembly. FIG. 2 is a side cross-sectional view of the distal end of the device of FIG. 1 having a combined inflated balloon and an implanted stent. 2 is a cross-sectional view of an exemplary proximal end of the apparatus of FIG. 1 according to another aspect of the invention. FIG. 6 is a plan view illustrating the distal end of another embodiment of a stent delivery device, according to another embodiment of the invention. FIG. 8 is a side view of the distal end of the stent delivery device of FIG. 7 in accordance with an aspect of the present invention. FIG. 6 is a perspective view of the distal end of another embodiment of a stent delivery device according to one aspect of the invention. FIG. 10 is a perspective view of the distal end of the stent delivery device of FIG. 9 showing a deployed expandable assembly in accordance with an aspect of the present invention. It is a perspective view of another embodiment of the stent delivery device of the present invention. FIG. 12 is another perspective view showing the distal end of the transport device of FIG. 11 prior to coupling the restricting member to the transport device. FIG. 12 is a perspective view of the distal end of the transport device of FIG. 11 showing a restricting member partially coupled to the transport device. FIG. 12 is a side view of another restriction mechanism that can be used with the transport apparatus of FIG. 11 in accordance with an aspect of the present invention. FIG. 6 is a perspective view illustrating another embodiment of a stent delivery device according to an aspect of the present invention. FIG. 16 is a perspective view showing the distal end of the transport device of FIG. 15 before coupling the regulating mechanism to the transport device. It is a side view of the conveying apparatus of FIG. 15 which shows the control member partially couple | bonded with the conveying apparatus. It is a side view of the conveying apparatus of FIG. 15 which shows the control member partially couple | bonded with the conveying apparatus. It is a side view of the conveying apparatus of FIG. 15 which shows the control member partially couple | bonded with the conveying apparatus. FIG. 6 is a perspective view illustrating another embodiment of a stent delivery device according to another aspect of the present invention. FIG. 6 is a perspective view illustrating another embodiment of a stent delivery device according to another aspect of the present invention. It is a side view of the conveying apparatus shown in FIG. 21 before couple | bonding a control mechanism to a conveying apparatus. It is a side view of the conveying apparatus of FIG. 21 which shows the control member partially couple | bonded with the conveying apparatus. FIG. 22 is a perspective view of the transport device of FIG. 21 having a restriction mechanism coupled to its distal end. FIG. 10 is a perspective view of the proximal end of another embodiment of a stent delivery device, in accordance with another aspect of the present invention. FIG. 6 is a perspective view of the proximal end of yet another embodiment of a stent delivery device, in accordance with another aspect of the present invention. FIG. 6 is a perspective view of the proximal end of yet another embodiment of a stent delivery device, in accordance with another aspect of the present invention. FIG. 9 illustrates another embodiment of the proximal end of another embodiment of a stent delivery device according to another aspect of the invention. FIG. 6 is a side cross-sectional view of another embodiment of a stent delivery device of the present invention according to another aspect of the present invention. FIG. 31 is a cross-sectional side view of the distal end of the stent delivery device of FIG. 30 in accordance with another aspect of the present invention. 6 is a cross-sectional side view of another embodiment of a stent delivery device according to another aspect of the present invention. FIG. 6 is a cross-sectional side view of another embodiment of a stent delivery device according to another aspect of the present invention. FIG. 6 is a cross-sectional side view of another embodiment of a stent delivery device according to another aspect of the present invention. FIG. FIG. 6 is a side cross-sectional view of yet another embodiment of a stent delivery device according to another aspect of the present invention. FIG. 6 is a side cross-sectional view of yet another embodiment of a stent delivery device according to another aspect of the present invention. 6 is a cross-sectional side view of another embodiment of a stent delivery device according to another aspect of the present invention. FIG. It is a sectional side view which shows embodiment of the stent delivery apparatus containing the embolism prevention apparatus by another aspect of this invention. FIG. 38 is a side cross-sectional view of the distal end of the transport device of FIG. 37. FIG. 38 is a side cross-sectional view showing a portion of the transport apparatus of FIG. 37 with the filter assembly deployed, according to another aspect of the present invention. FIG. 38 is a cross-sectional side view of a portion of the delivery apparatus of FIG. 37 with the filter assembly and stent deployed according to another aspect of the present invention. FIG. 38 is a perspective view of a restriction mechanism for a filter assembly that can be used with the transport apparatus of FIG. 37 according to another aspect of the present invention. FIG. 38 is a perspective view of a filter assembly that can be used with the transport apparatus of FIG. 37 according to another aspect of the present invention. FIG. 43 is a perspective view of an embodiment of the filter assembly of FIG. 42 according to another aspect of the invention. FIG. 7 is a perspective partial cross-sectional view showing the distal end of another embodiment of a transport apparatus according to another aspect of the present invention. 1 is a perspective view of an embodiment of a capture mechanism according to one aspect of the present invention. FIG. FIG. 6 is a perspective view of another embodiment of a capture mechanism according to an aspect of the present invention.

Claims (30)

An expandable assembly;
A stent disposed on the expandable assembly;
A guide member having a proximal end and a distal end, wherein the distal end of the guide member includes one or more struts and is configured to selectively regulate the expandable assembly; A guide member in which the expandable assembly and the stent are simultaneously placed in a body lumen by disposing the guide member in a lumen of the body;
A restricting member that cooperates with the surface of the distal end and assists in applying a restricting force to the distal end to restrict the expandable assembly and the stent;
The extending along the guide member, wherein coupled to the regulating member in order to selectively displace the regulating member, viewed contains at least one actuating member, the regulating member may select one or more struts A stent delivery device adapted to deliver a stent into a body lumen, characterized in that the cord is a sewn cord .   The guide member includes a lumen extending between the proximal end and the distal end of the guide member, and the expandable assembly and the stent are selectively restricted within the lumen of the guide member. The apparatus of claim 1. The expandable assembly is
An inflatable balloon including an inner portion;
The apparatus of claim 1, further comprising an expandable tube in fluid communication with the inner portion of the expandable balloon. 4. The apparatus of claim 3 , wherein the expandable tube includes a plurality of openings that communicate with the inner portion of the expandable balloon. The expandable tube further comprises a positioning member that cooperates with the expandable balloon, the positioning member adapted to move the expandable assembly and the stent in at least one of a proximal direction and a distal direction. 4. The device according to claim 3 , wherein: The apparatus of claim 5 , wherein the positioning member is adapted to cooperate with the expandable tube. The apparatus of claim 1 , wherein the distal end of the guide member includes one or more struts biased to open outward. 8. The apparatus of claim 7 , wherein the one or more struts are integrally formed with the guide member. 8. The apparatus of claim 7 , wherein at least one of the one or more struts forms an atraumatic tip. The apparatus of claim 1 , wherein the at least one actuating member is positioned to pass through a lumen of the guide member. The apparatus of claim 1 , wherein the cord is configured into a plurality of hoops, the plurality of hoops being selectively secured by at least a portion of the at least one actuation member. The apparatus of claim 1 , wherein the proximal end of the guide member is adapted to cooperate with an actuating element. The actuating element cooperates with one or more actuating members, the one or more actuating members assisting in releasing the expandable assembly and the stent from restriction by the distal end of the guide member. 13. The device according to claim 12 , characterized in that: A stent delivery device configured to deliver a stent to a body lumen comprising:
An expandable assembly;
A stent disposed on the expandable assembly;
A guide member having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end of the guide member, wherein the distal end of the guide member includes one or more struts. And cooperating with a restricting member adapted to cooperate with the surface of the distal end and to selectively restrict the distal end to restrict the expandable assembly and the stent. A guide member configured to selectively restrict the expandable assembly;
A guide wire extending along the length of the guide member, wherein the guide wire is at least partially disposed within the lumen of the guide member;
A restriction member configured to selectively position the one or more struts between a restriction position and a release position;
At least one actuating member extending along the guide member and coupled to the restricting member to selectively displace the restricting member;
By placing the guide member within the body lumen, at the same time, the expandable assembly and the stent are disposed within the body lumen ;
The apparatus is characterized in that the restricting member is a cord selectively fixed to the one or more support columns . The apparatus of claim 14 , wherein the guidewire passes through the expandable assembly. 15. The device of claim 14 , wherein the guidewire passes between the expandable assembly and the stent. 15. The device of claim 14 , wherein the guidewire passes between the stent and the guide member. The apparatus of claim 14 further comprising a protective tip disposed at the distal end of the guide member. The expandable assembly comprises:
An inflatable balloon having an inner portion;
The device of claim 14 , comprising an expandable tube in fluid communication with the inner portion of the expandable balloon. The apparatus of claim 19 , wherein the expandable assembly further includes a tubular member adapted to receive the guidewire, the expandable balloon being disposed about the tubular member. 21. The positioning member according to claim 20 , further comprising a positioning member coupled to the expandable assembly, the positioning member having sufficient rigidity to move the expandable assembly in a distal direction or a proximal direction. Equipment. The positioning member is coupled to the inflatable tube, the positioning member according to claim 21, characterized in that it has a sufficient rigidity to move the inflatable tube on at least one of the distal or proximal direction The device described in 1. 23. The apparatus of claim 22 , wherein the positioning member is disposed within the expandable tube. 23. The positioning member according to claim 22 , wherein the positioning member is coupled to the guide wire, and the positioning member is rigid enough to move the guide wire in at least one of a distal direction and a proximal direction. Equipment. Wherein the distal end of the guide member comprises one or more struts, at least one of said one or more struts according to claim 19, characterized in that it is biased to open outwards apparatus. 26. The apparatus of claim 25 , wherein the one or more struts are integrally formed with the guide member. 15. The apparatus of claim 14 , wherein the at least one actuation member is disposed to pass through a lumen of the guide member. And an actuating element coupled to the at least one actuating member, the actuating element adapted to move the at least one actuating member in a direction selected from the group consisting of a proximal direction or a distal direction. The apparatus according to claim 14 . 29. The apparatus of claim 28 , wherein the actuating element cooperates with the proximal end of the guide member. And further comprising an expandable tube having a proximal end and a distal end, wherein the distal end of the expandable tube is in fluid communication with an expandable balloon of the expandable assembly, and the proximal end of the expandable tube is 30. The device of claim 29 , wherein the device is coupled to the actuating element.

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